MEDLINE INDUSTRIES, LP - Northfield recalls Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorde

Recalled July 10, 2024 · FDA recall Z-2231-2024 · MEDLINE INDUSTRIES, LP - Northfield

Hazard

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. · FDA Class II

Units

7,673 total non-sterile kits

Sold at

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

Description

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Product

Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.

Manufacturer(s)

MEDLINE INDUSTRIES, LP - Northfield

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →